Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial.

Autor: Merrill PT; Illinois Retina Associates, Chicago, IL, USA.; Rush University Department of Ophthalmology, Chicago, IL, USA., Henry CR; Retina Consultants of Texas, Houston, TX, USA.; Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA., Nguyen QD; Stanford University Medical Center, Palo Alto, CA, USA.; Byers Eye Institute, Stanford University School of Medicine, Palo Alto, CA, USA., Reddy A; Athena Eye Institute, San Antonio, TX, USA., Kapik B; Clearside Biomedical, Alpharetta, GA, USA., Ciulla TA; Clearside Biomedical, Alpharetta, GA, USA.
Jazyk: angličtina
Zdroj: Ocular immunology and inflammation [Ocul Immunol Inflamm] 2023 Oct; Vol. 31 (8), pp. 1579-1586. Date of Electronic Publication: 2021 Aug 18.
DOI: 10.1080/09273948.2021.1954199
Abstrakt: Purpose: To study the efficacy and safety of suprachoroidal CLS-TA (proprietary suspension of triamcinolone acetonide) in uveitic macular edema (UME) with and without concurrent systemic corticosteroid or steroid-sparing therapy (ST).
Methods: Post hoc analysis of the PEACHTREE phase 3 randomized trial.
Results: Among UME patients receiving no ST, at week 24, mean BCVA change was +15.6 letters in 68 CLS-TA patients versus +4.9 letters in 49 sham-control patients ( p < .001), while mean CST change was -169.8 µm versus -10.3 µm, respectively ( p < .001). Among patients receiving ST, at week 24, mean BCVA change was +9.4 letters in 28 CLS-TA patients versus -3.2 letters in 15 sham-control patients ( p = .019), while mean CST change was -108.3 µm versus -43.5 µm, respectively ( p = .190). No SAEs related to treatment were reported.
Conclusions: A clinically meaningful benefit of CLS-TA was noted in UME patients, regardless of concurrent ST usage. Abbreviation and Acronyms CST = central subfield thickness; BCVA = best corrected visual acuity; ME = macular edemaI; IVT = intravitreal; AE = adverse event; FA = fluocinolone acetonide; SD-OCT = spectral-domain optical coherence tomography; NIU = noninfectious uveitis; SAE = serious adverse event; TEAE = treatment emergent adverse event; ITT = intent to treat; CI = confidence interval.
Databáze: MEDLINE
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